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| | Ortho-Clinical Diagnostics, Inc., Issues a Voluntary Product Recall for... |
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date: Apr 4th 2006 14:00
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VITROS® Immunodiagnostic Products Signal Reagent.
Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company, has initiated a nationwide voluntary product recall of a reagent used with its VITROS® Immunodiagnostic ECi/ECiQ laboratory test system because the reagent may produce inaccurate tests results in some cases. This reagent is a special chemical used in the test system by laboratories to test patient samples.
The reagent being recalled is the VITROS® Immunodiagnostic Products Signal Reagent (SR), used on the VITROS® Immunodiagnostics ECi/ECiQ System. The test system is used in clinical laboratories to screen for more than 40 diseases and conditions. This recall affects two of 50 lots of this reagent (or four percent) currently in distribution globally. One lot being recalled was distributed in the U.S., and one in countries outside the U.S.
Inaccurate test results may affect test outcomes in these critical areas: cardiac (heart attack) hepatitis (A, B or C) thyroid disorders HIV and pregnancy. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results are recommended to discuss this matter with their physicians.
Ortho-Clinical Diagnostics, Inc., has advised laboratories using this reagent to contact the patient s physician if there are any concerns regarding previous test results.
This voluntary product recall includes:
VITROS® Signal Reagent, Lot 8350, catalog 107 2693
VITROS® Signal Reagent, Lot 8530, catalog 107 2693
Ortho-Clinical Diagnostics, Inc., initiated a voluntary product recall by notifying all distributors and customers with a VITROS® ECi/ECiQ System. Customers with the affected lots were asked to immediately discontinue using any remaining VITROS® SR Lot 8350 or 8530 if alternate lots were in inventory and to follow an enhanced Quality Control (QC) procedure for all lots of VITROS® Signal Reagent until further notice. This precautionary measure is designed to identify any potential packs of affected VITROS® Signal Reagent.
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